FDA Transparency Blog

You probably know that health care professionals, manufacturers, and consumers often report adverse events from medical products to FDA, and that these reports are of great value to the Agency in learning about new risks of marketed products.

But did you know that FDA now has another way of monitoring medical product safety?  This new way uses information from health care records and other data sources that still protects patient privacy.  It can also provide information to FDA safety scientists in a fraction of the time it could take to get similar information from other FDA sources.

This new FDA tool is called “Mini-Sentinel,” a working pilot project of the Agency that uses secure access to the electronic health records of more than 125 million people, now enabling FDA researchers to actively seek out safety information, in addition to receiving it in reports.

FDA will host a webinar titled, “Mini-Sentinel,” FDA’s New Tool for Monitoring the Safety of FDA-Approved Medical Products highlighting this new FDA capability on April 24, 2012 at 12:00 PM ET.

There are a limited number of spots available for the webinar.  Materials from the webinar will also be made available on the FDA Basics website following the presentation.

Learn more about the webinar, including instructions about how to join.